Search Results

The INOmax DSIR® Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling.

The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired 02, NO2, and NO.

The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss.

The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.

The INOmax DSIR® uses a "dual-channel" design to provide delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shut down INOMAX® delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

The INOmax DSIR Plus MRI incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DSIR Plus MRI includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO, which along with user supplied 10 L/min of oxygen, provides 20 ppm of NO to a patient breathing circuit. The INOblender® can also be used for backup.

The provided document is a 510(k) summary for the INOmax DSIR® Plus MRI, a nitric oxide administration apparatus. It outlines the device description, intended use, technological characteristics, and a comparison to a predicate device, as well as a summary of nonclinical tests performed.

However, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of typical AI/ML medical device submission requirements.

Here's why and what information can be extracted or deduced:

This document describes a hardware medical device, not an AI/ML powered software or diagnostic device. Therefore, the concepts of "acceptance criteria" and "device performance" as typically discussed for AI/ML models (e.g., sensitivity, specificity, AUC) are not directly applicable in the same way. The "performance" here refers to the device's functional operation meeting engineering specifications.

Let's address each point based on the available information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Deduced from testing goals): The document implies acceptance criteria are related to the device's functional performance:

  • O2 dilution: The device should not unacceptably dilute oxygen concentration.
  • Effect on delivered pressures: The device should not adversely affect ventilator delivered pressures.
  • INOmax DSIR® delivery accuracy: The device should accurately deliver Nitric Oxide.
  • NO2 generation: The device should not generate unacceptable levels of Nitrogen Dioxide.
  • MRI Compatibility: Device classified as MR Conditional for 1.5 Tesla and 3.0 Tesla static magnetic field scanners in areas where field strength is less than 100 gauss (via ASTM standards and other tests).
  • Electrical Safety & EMC: Conformity to IEC 60601-1 and IEC 60601-1-2.
  • Alarm Systems: Conformity to IEC 60601-1-8.
  • Software Functionality: Software version 3.1.2 meets specified requirements.
  • Usability: Meets human factors engineering requirements (ANSI/AAMI HE75).
  • Backup delivery: Provides fixed flow of 250 mL/min of NO.

• Reported Device Performance:

  • "The INOmax DSIR® performed within published specifications when used with each of the ventilators in both primary and backup delivery."
  • "The INOmax DSIR® Plus MRI meets its system level requirements and that the new/modified features function as specified."
  • Compliance with specific FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ASTM F2052-06, ASTM F2119-07, ASTM F2503-13).

Table of (Deduced) Acceptance Criteria and Performance:

Ask a specific question about this device

The INOmax® DS delivery system delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax® DS provides continuous integrated monitoring of inspired O₂, NO₂, and NO, and a comprehensive alarm system.

The INOmax® DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax® DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.

The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR® uses a "dual-channel" design to ensure the safe delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO₂, and O₂ cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX® delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

The provided document describes the INOmax DSIR® (Delivery System), a device for delivering nitric oxide to patients. The submission is a 510(k) for a software update (version 3.0) and compatibility with two additional respiratory care devices (Hamilton C1 and T1 Ventilators).

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes testing for the new software version and compatibility with two new ventilators. The "test set" consisted of:

• Two additional respiratory care devices: Hamilton C1 Ventilator (K120574) and Hamilton T1 Ventilator (K120670).
• INOmax DSIR® settings: Five settings were used: 0 (baseline), 1, 5, 20, 40, and 80 ppm, for each setting and mode of ventilation, as well as the Backup mode.

The data provenance is non-clinical testing, performed in a controlled laboratory setting (likely within the company or a certified testing facility). There is no indication of country of origin of the data, but the company is based in Madison, Wisconsin, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

There is no mention of "experts" being used to establish ground truth in the context of the device's technical performance. The "ground truth" for this engineering validation would be the physical measurements taken by calibrated instruments, and the functionality verification against predetermined specifications. The text does not refer to human experts evaluating the "ground truth" of the device's performance characteristics.

4. Adjudication Method for the Test Set

Not applicable. This was a technical performance verification study, not a study involving human interpretation where adjudication would typically be used to resolve discrepancies in expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, INOmax DSix®, with updated software and interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was effectively a standalone performance evaluation of the device. The testing described assesses the device's ability to accurately deliver nitric oxide, monitor gases, and function with specific ventilators, without human intervention being part of the performance measurement itself (though human users operate the system). The tests focused on the device's intrinsic mechanical and software performance.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was instrumental measurements of various parameters (e.g., O2 dilution, delivered pressures, NO delivery accuracy, NO2 generation) and functional verification against predetermined specifications for software features and alarms.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware/software system, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "software update" refers to deterministic code changes and feature enhancements, not a learned model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/ML. The "ground truth" for the device's design and functionality would be established through engineering specifications, previous predicate device performance, and compliance with recognized standards.

Ask a specific question about this device

The INOmax® DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax® DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax® DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax® DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.

The target patient population is controlled by the drug labeling for INOmax® and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR® uses a "dual-channel" design to ensure the safe delivery of INOmax®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax® delivery independent of monitoring but also allows the monitoring system to shutdown INOmax® delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

Here's an analysis of the provided text regarding the INOmax DSIR device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a compatibility study rather than a traditional performance study with explicit numerical acceptance criteria for accuracy metrics. The study aims to demonstrate substantial equivalence by confirming compatibility with additional respiratory care devices. Therefore, the "acceptance criteria" are implied to be the device performing within its published specifications and meeting the four necessary requirements for compatibility.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text states, "Five INOmax DSIR® settings were used [0 (baseline), 1, 5, 20, 40, and 80 ppm] for each setting and mode of ventilation, as well as the Backup mode." It also mentions "both devices were set up and calibrated... and tested using the settings established for each respiratory care device test." The "new respiratory care devices" are the Drager Apollo Anesthesia Ventilator and the CareFusion ReVel Ventilator.
  • This implies testing across different modes of ventilation (which are not specifically enumerated, but would be several for each ventilator) and these 6 concentrations for each mode, for both primary and backup delivery, across two different new ventilators.
  • While specific case numbers aren't given in a medical imaging sense, the "sample size" here refers to the extensive set of configurations and parameters tested: 2 ventilators * (multiple modes) * 6 NO concentrations * 2 delivery types (primary/backup).
• Data Provenance: The study is nonclinical (laboratory testing) and was conducted by the submitter (INO Therapeutics doing business as Ikaria). The country of origin is not explicitly stated but can be inferred to be the USA, where the company is based and where the 510(k) submission was made. The study is prospective as it involves active testing of the device under specific conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of nonclinical, engineering-focused study does not typically involve human experts establishing "ground truth" in the way a clinical diagnostic study would. The "ground truth" in this context is the objectively measured performance of the device against its own published specifications and the expected behavior of the ventilators. The measurements would be taken by trained technicians or engineers following established protocols. No information is provided about expert qualifications or numbers beyond "manufacturer's recommendations" for setup and calibration.

4. Adjudication Method (for the test set)

No formal adjudication method (like 2+1 or 3+1 consensus) is described, as this is not a study involving human interpretation of clinical data. The "adjudication" is based on objective measurements and comparison against established specifications. "Any anomalies found" were recorded, implying a review of results by the testing personnel.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a nonclinical, engineering compatibility test, not a clinical study involving human readers or cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study in the sense that it evaluated the performance of the device (INOmax DSIR®) itself when interfaced with two specific ventilators. There was no human-in-the-loop component being evaluated for its diagnostic or therapeutic effectiveness; rather, the device's ability to maintain its intended performance characteristics in a new configuration was assessed.

7. The Type of Ground Truth Used

The ground truth used was objective performance measurements of the INOmax DSIR® against its published specifications and the expected operational parameters of the ventilators (e.g., delivered oxygen concentration, pressure, NO concentration, NO2 generation).

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This is a conformance and compatibility test, not a machine learning study.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

Ask a specific question about this device

The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The INOblender is designed to take constant oxygen (02) gas flow (5 to 14 L/min) from the integrated O2 flowmeter and blend in NO at the setting on the NO blender's concentration control dial (5 to 80 ppm). The NO blender is calibrated for cylinder concentrations of 800 ppm NO in a balance of nitrogen (N2).

The provided document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML diagnostic devices. This document is a 510(k) summary for a medical device called INOblender®, which is a Nitric Oxide administration apparatus.

Here's why the requested information cannot be fully provided from this document:

• Device Type: The INOblender® is a physical medical device (blender for gas delivery), not an AI/ML diagnostic software or algorithm. Therefore, the concepts of "algorithm only performance," "human readers improve with AI," "ground truth establishment" of a "test set" and "training set" in the context of diagnostic accuracy are not applicable.
• Study Type: The submission is primarily focused on demonstrating substantial equivalence to a predicate device, not on proving diagnostic accuracy or effectiveness through clinical trials in the sense of AI/ML performance.

However, I can extract information related to the device's non-clinical testing which serves as the "study" demonstrating its capabilities.

Here's a breakdown of the available information based on your request, adapted to the context of this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative table with specific targets and achieved results. Instead, it lists four requirements that were tested for compatibility with a new respiratory care device. The "reported device performance" is the conclusion that these requirements were met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of diagnostic data. The "test set" here refers to the device itself and its interaction with a specific new respiratory care device. The testing was conducted by setting up the INOblender® and the new respiratory care device. The number of such setups or repetitions is not specified, but it's not data in the sense of patient cases.
• Data Provenance: Not applicable in the context of diagnostic data. The "testing" refers to equipment performance validation, likely conducted in a laboratory setting by the manufacturer. Details like country of origin for such engineering tests are not provided and typically not relevant for this type of submission. The tests were "non-clinical."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for this type of device. The "ground truth" for these tests would be the known operational parameters and specifications of the devices themselves and the physical/chemical measurements taken during the compatibility and performance tests.
• Qualifications of Experts: Not applicable. The "experts" involved would be engineers and technicians performing the physical and chemical tests, adhering to established protocols. Their specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of diagnostic data. For physical device performance testing, the results are typically objectively measured and compared against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of the INOblender®.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The INOblender® is a physical device that functions to deliver gas, not an algorithm. Its "standalone" performance would relate to its ability to accurately blend and deliver gases according to its specifications. The document states "INOblender® NO dose delivery accuracy" was tested, which can be considered a standalone performance aspect for the device's primary function.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the non-clinical tests was established by known engineering specifications, physical/chemical measurement standards, and the manufacturer's recommendations for calibration and operation. For example, "NO dose delivery accuracy" would be compared against a known, precise NO concentration generated by the device itself or measured by a calibrated external sensor.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no AI/ML algorithm involved, so there is no "training set" in the context of machine learning. The device is hardware-based, relying on established physical and chemical principles.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable for the reasons mentioned above.

Summary of Device-Specific Information:

• Device Name: INOblender®
• Intended Use: To provide user-set concentrations of inhaled Nitric Oxide (NO) mixed into a constant flow of oxygen gas. Intended as a backup to a primary NO delivery system or for short-term attended use when a primary device is impractical.
• Technology: Component technology (blender, regulator, NO gas tank).
• Predicate Device: K052663 (another INOblender® with slightly different labeling for compatibility with resuscitators).
• Non-Clinical Tests:
  • O2 dilution
  • Effect on respiratory care device (compatibility with Fisher & Paykel NeoPuff)
  • INOblender® NO dose delivery accuracy
  • NO2 generation
• Clinical Tests: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." (Meaning, no clinical tests were performed for this specific submission, as it relied on non-clinical data and substantial equivalence to a predicate).

Ask a specific question about this device

The INOmax® DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax® DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax® DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax® DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.

The target patient population is controlled by the drug labeling for INOmax® and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR® uses a "dual-channel" design to ensure the safe delivery of INOmax®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax® delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes software and labeling modifications to the INOmax DSIR, focusing on alarm thresholds and compatibility with new respiratory care devices. The acceptance criteria are implicitly met by successful verification testing. The performance is described by how the modified alarms function and successful compatibility testing.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of cases or patients. Instead, it refers to testing conducted with:
  • Five INOmax DSIR® settings: 0 (baseline), 5, 20, 40, and 80 ppm, "for each setting and mode of ventilation." This implies a systematic study across different operational parameters.
  • Three new respiratory care devices: Fisher & Paykal Infant Circuit Nasal Cannula (K020332), Fisher and Paykal Optiflow Breathing Circuit (K983112), and A-Plus Medical Babi Plus Bubble CPAP (K110471).
• Data Provenance: The testing described is non-clinical and conducted by the manufacturer, INO Therapeutics/Ikaria. The data is thus prospective internal testing data. The country of origin is not explicitly stated for the testing, but the company is based in Madison, Wisconsin, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. The testing described is non-clinical performance and compatibility testing of a medical device, not a diagnostic algorithm that relies on expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable to the type of non-clinical device testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is needed for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This document describes the premarket notification for a medical device (nitric oxide delivery system), not an AI-based diagnostic tool or system designed to assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone system for delivering nitric oxide and monitoring gases. The document describes "software verification" and "performance testing" of the device, which inherently represents its standalone (without human intervention once settings are applied) functionality for its intended purpose. The modifications discussed pertain to the internal logic and alarm triggers of this standalone system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by:

• Technical Specifications/Requirements: The device is tested against its established system-level requirements and specifications, as well as recognized consensus standards (e.g., IEC 60601 series).
• Physical Measurements: For performance aspects like NO delivery accuracy, measured values from the INOmax DSIR® are recorded and compared against known input settings.
• Functional Verification: For alarms and compatibility, the "ground truth" is whether the alarm triggers as expected under specified conditions or if the integration with other devices functions without issues and meets predefined operational criteria (e.g., no detrimental O2 dilution, no adverse effect on respiratory care device).

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable to this document. The INOmax DSIR® is a hardware device with embedded software; it does not utilize machine learning or AI that requires a training set in the conventional sense. The "training" for the software's development would implicitly come from the extensive design, development, and iterative testing processes, but not from a distinct, labeled "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" in the context of machine learning, the question of how its ground truth was established is not applicable. The "ground truth" for the device's design and functionality is derived from engineering specifications, medical device standards, risk analysis, and clinical requirements for patient safety and efficacy.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

The provided document describes the INOmax DSIR, a nitric oxide delivery system, and its compatibility with additional respiratory care devices. The submission focuses on non-clinical testing to demonstrate substantial equivalence, rather than a study involving clinical outcomes or diagnostic accuracy. Therefore, information related to observer performance studies (e.g., MRMC studies, standalone performance), ground truth establishment for diagnostic tasks, expert qualifications, and adjudication methods is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing involving the INOmax DSIR and three specific respiratory care devices:

• (K102775) Hamilton C2
• (K070513) Hamilton G5
• (K100011) Fisher & Paykel Healthcare Bubble CPAP System

The testing involved using six INOmax DSIR settings: [0 (baseline), 1, 5, 20, 40] ppm (the sixth value is cut off but implied to be another concentration in ppm). The document states, "The three respiratory care devices were set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for each respiratory care device test." This suggests a systematic testing approach across different settings for each device. However, a specific numerical "sample size" in terms of number of patient cases or repeated measurements for statistical analysis is not detailed in the provided text.

The data provenance is prospective non-clinical testing conducted by INO Therapeutics/Ikaria, likely at their facilities, to evaluate compatibility and performance. There is no indication of country of origin of patient data as no patient data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring expert-established ground truth. The "ground truth" was the expected performance according to published specifications and manufacturer recommendations for the devices.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. No MRMC study was conducted, as this submission concerns the hardware and software performance of a nitric oxide delivery system and its compatibility with other respiratory devices, not a diagnostic algorithm involving human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The INOmax DSIR is a medical device for delivering and monitoring nitric oxide, not a standalone diagnostic algorithm. Its performance was tested as a standalone system and in conjunction with other respiratory care devices.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing was based on:

• Manufacturer's specifications: The INOmax DSIR was expected to "perform within published specifications."
• Manufacturer's recommendations: The respiratory care devices were set up and calibrated "according to the manufacturer's recommendations."
• Expected compatibility: The overall aim was to conclude that the INOmax DSIR and the three respiratory care devices are compatible.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware and software system for medical gas delivery and monitoring, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2 and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

The provided text describes the INOmax DS delivery system and its acceptance criteria, primarily focusing on its compatibility with the Vapotherm Precision Flow system. It does not contain information about a study proving the device meets the acceptance criteria in the typical sense of a clinical statistical study for AI/machine learning devices. Instead, it describes non-clinical engineering tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO3, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

The provided document describes the INOmax DSIR delivery system for nitric oxide and its compatibility with additional ventilators. The study discussed is a non-clinical test to establish substantial equivalence for the updated device rather than an AI-powered diagnostic tool, therefore many of the requested criteria are not applicable.

Here's an analysis of the provided information, focusing on the relevant sections and explicitly stating when information is not applicable (N/A) for this type of device and study:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:
  • Five INOmax DSIR settings were used: 0 (baseline), 1, 5, 20, 40, and 80 ppm.
  • These settings were applied for each setting and mode of ventilation/patient cannula for the five additional respiratory care devices.
  • The "Backup mode" was also tested for each.
  • (Note: The document doesn't specify the number of times each setting/mode combination was tested or the duration of each test).
• Data Provenance: Not specified, but implied to be from laboratory testing related to the submitter (INO Therapeutics/Ikaria). The study is prospective in that it was conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This was a non-clinical engineering and performance study of a medical device, not a diagnostic study requiring expert human interpretation of data for ground truth. The "ground truth" was the physical performance of the device against predefined technical specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. As this was a non-clinical performance study, there was no need for human adjudication of results in the way it's applied in diagnostic studies. The results were measured and recorded against established device specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This study is not an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. It's a non-clinical compatibility and performance test of a medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This device does not have an "algorithm only" component in the diagnostic sense that would be tested for standalone performance. The device itself is the "system" being tested.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this non-clinical study was the published specifications of the INOmax DSIR and the compatibility requirements for its operation with the selected ventilators. The testing aimed to demonstrate that the device performed within these established specifications.

8. The sample size for the training set

N/A. There is no mention of a training set as this is a non-clinical device performance study, not an AI or machine learning model development.

9. How the ground truth for the training set was established

N/A. There is no training set for this type of non-clinical device performance study.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DS2 uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

The provided submission for the INOmax DS by INO Therapeutics/Ikaria does not contain acceptance criteria or a study that explicitly details device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K061901; INOmax DS (Delivery System)) through non-clinical testing and compliance with regulatory guidance.

Here's a breakdown of the information that is available, and what is missing for each point you requested:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated in a quantifiable, pass/fail table format. The submission mentions compliance with "voluntary standards" (Section 9 and 17, not provided) and the "Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer" (January 24, 2000) FDA-1157. However, the specific performance requirements from these standards are not detailed in the summary.
   • Reported Device Performance: The submission states that "The SVRS testing, the summary of which is described in appendix J of this submission, thoroughly tested all requirements of the software, including the NO delivery and gas monitoring performance. The successful completion of these tests demonstrated that the INOmax DS (Version 2) met the performance requirements of the original product and the new requirements of the revised device." However, the actual results of these performance tests (e.g., accuracy of NO delivery within X% of set value, response time for alarms, battery life under specific conditions) are not provided in the summary.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not applicable as no clinical studies were performed. For non-clinical (engineering/software) testing, sample sizes are not typically reported in this context, nor is data provenance in terms of country of origin. The testing described is prospective, in the sense that it was conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable, as no clinical studies requiring expert ground truth were conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable, as no clinical studies requiring adjudication were conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No MRMC study was conducted. This device is a medical gas delivery system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • The "standalone" performance in this context refers to the device's technical specifications and functionality, which were tested via "SVRS testing" and "hardware changes" assessment. The submission claims these tests demonstrated the device met "performance requirements," implying standalone testing was indeed performed, but the specific results are not provided. The device itself operates without human interpretation of its core function (gas delivery).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards outlined in the voluntary standards and FDA guidance document (e.g., a known, precisely measured concentration of NO for testing analyzer accuracy, or a defined electrical load for battery life testing). These specific internal standards are not detailed in the summary.

8. The sample size for the training set

   • Not applicable, as no machine learning/AI model requiring a training set is described for this device.

9. How the ground truth for the training set was established

   • Not applicable, as no machine learning/AI model requiring a training set is described for this device.

Summary of Device Features and Testing Mentioned:

• Device: INOmax DS (Delivery System) - delivers INOmax (nitric oxide for inhalation) therapy gas.
• Key Design: "Dual-channel" for safe delivery and monitoring (delivery CPU + flow controller + injector module; separate monitor CPU + gas cells for NO, NO2, O2 + user interface).
• New Features (for this revision): Patient data storage and additional operational alarms.
• Technology Changes: Ergonomic changes for data collection (patient parameters/device usage) and additional notifications/alerts (visual and audible). Infrared communication added for data transfer, and GUI changed for visual notifications.
• Non-Clinical Tests:
  • Compliance with voluntary standards (Sections 9 and 17).
  • Hardware changes (infrared features) assessed; determined not to affect original functions extensively; connected to common power source and serial data link to battery and monitoring processor.
  • SVRS (Software Verification and Validation Requirements Specification) testing of all software requirements, including NO delivery and gas monitoring performance.
  • Compliance with "Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer" (January 24, 2000) FDA-1157.
  • Conclusion: Verified that additional communication and alarms did not alter safety or effectiveness.
• Clinical Studies: None required or conducted to support substantial equivalence.

In conclusion, based on the provided text, the submission focuses on documenting substantial equivalence through compliance with existing standards and software/hardware verification testing, rather than presenting a formal study with explicit acceptance criteria and corresponding performance data as might be expected for novel diagnostic algorithms.

Ask a specific question about this device

The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INO Therapeutics INOmax DS represents the continuing evolution of the Datex-Ohmeda (now GE Healthcare) INOvent Delivery System design. Its published performance specifications are not significantly different from the INOvent. The INOmax DS design incorporates a reconfiguration of hardware, electronic circuitry and software resulting in a more compact, stylish, modern, user-friendly and easier manufactured product.

The INOmax DS delivery system delivers INOmax® (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed iniector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The provided text describes the INOmax DS (Delivery System), a nitric oxide administration apparatus. However, it explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, information regarding acceptance criteria derived from clinical studies, comparative effectiveness studies, or clinical ground truth establishment is not available within the provided document.

The document primarily focuses on non-clinical tests and the device's technological equivalence to a predicate device.

Here's an analysis based only on the provided text, addressing the requested points:

Acceptance Criteria and Device Performance

Since clinical studies were not required for this 510(k) submission, there are no specific performance acceptance criteria or reported device performance metrics from clinical trials mentioned. The manufacturer's conclusion is that the INOmax DS is "as safe, as effective, and performance is substantially equivalent to the predicate device."

Other Information

Due to the lack of clinical studies, much of the requested information is not present in the provided document.

2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for performance evaluation is mentioned. Non-clinical testing details (e.g., number of units tested, specific data provenance) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth is mentioned.
4. Adjudication method for the test set: Not applicable, as no clinical test set is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a nitric oxide delivery system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for nitric oxide delivery, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth establishment is mentioned. The primary basis for equivalence is technological similarity and compliance with voluntary standards and internal quality assurance measures, rather than a clinical ground truth.
8. The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device